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Introduction

Sciensus was delighted to partner with Fierce Biotech and host a webinar on June 25th 2024. The topic was Unlocking the European orphan drug market: the power of Expanded Access Programs (EAPs) and pan-European Real-World data collection.

The webinar delved into the benefits of Expanded Access Programs in Europe. Panelists discussed the crucial role of EAPs in achieving faster access to the European market, establishing a network through early engagement with healthcare professionals and Key Opinion Leaders, and utilizing real-world data gleaned from EAPs to support future regulatory submissions and market positioning. They also discussed how EAPs can help serve as introductions to the dizzying array of regulations and guidelines in European countries.

Featured speakers

The panel of industry experts included: 

Andrew Cummins, Director of Expanded Access Programs 

Mathieu Loiseau, Director of Rare Clinical Services  

Sara Radenovic, Director of Managed Access Programs at GSK 

Doctor and patient

Topics covered:

  • When is the optimal time to start your Expanded Access Program (EAP)?
  • What are the benefits of running an EAP?
  • What steps should you follow to establish a successful EAP?
  • Why is Real World Data collection valuable and how does it impact Health Technology Assessment (HTA) submissions?

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About Sciensus

Sciensus is a global network dedicated to getting rare medicines to hard-to-reach patients worldwide.​ For over 30 years, we’ve delivered on every aspect of this vital transaction; from early access all the way to full commercialisation, including patient support programs.

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